TMC Pharma Services offer a full range of medical support services

Medical services

Supporting the Sponsor's medical function:
- Representation of the Sponsor's medical function with investigators and health authorities
- Pharmacovigilance physician and product safety expert
- Participation in safety advisory boards
- Acting Chief Medical Officer

Medical support for clinical trials
- Medical input to protocol design
- Medical support to CRAs
- Responding to medical questions
- Evaluating lab results and other clinical parameters
- Visiting sites to solve medical issues
- Responding to ethics / regulatory medical questions
- Contributing to internal safety-monitoring groups
- Medical review of patient profiles and data listings
- Final study report reviews

Pharmacovigilance for clinical trials and postmarketing

Medical oversight of pharmacovigilance systems, including RP/QP services if required:
- Reviewing safety profile and risk/benefit analysis
- Reviewing SAE/pharmacovigilance reports
- Review of ASURs and PSURs

Medical marketing support
- Literature analysis and evaluation for marketing purposes
- Production of marketing support and training materials
- Writing or review of manuscripts for publication
- Sign-off of advertising copy